8/9/2023

speaker
Conference Operator
Call Moderator

Good morning, ladies and gentlemen, and welcome to the Brain's Way second quarter 2023 earnings conference call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, August 9th of 2023. I would now like to turn the conference over to Brian Ritchie with LifeSci. Please go ahead, sir.

speaker
Brian Ritchie
Conference Call Host, LifeSci

Thank you, and welcome to BrainsWay's second quarter 2023 earnings conference call. With us today are BrainsWay's Chief Executive Officer, Hadar Levy, and Chief Financial Officer, Ido Marom. The format for today's call will be a discussion of recent trends and business updates from Hadar, followed by a detailed discussion of the financials. Then we will open up the call for your questions. Earlier today, Brainsway released financial results for the three and six months ended June 30th, 2023. Copy of the press release is available on the company's investor relations website. Before I turn the call over to Hadar, I would like to remind you that this conference call, including both management's prepared remarks and the question and answer session, may contain projections, or other forward-looking statements regarding, among other topics, Brainsway's anticipated future operating and financial performance, business plans and prospects, and expectations for its products and pipeline, which are all subject to risks and uncertainties, including shifting market conditions resulting from the COVID-19 pandemic, the global supply chain crisis, as well as the use of non-GAAP financial information. Additional information regarding these and other risks are available in the company's earnings release and its other filings with the SEC, including the risk factors section contained in Brains Waste Form 20F. I would now like to turn the call over to Hadar.

speaker
Hadar Levy
Chief Executive Officer, BrainsWay

Thank you, Brian. Welcome, everyone, and thank you for joining us today. I'm pleased to report that our efforts toward implementing key initiatives aimed at growing the company's top line over 2022 while targeting breakeven operating income and positive adjusted EBITDA in the fourth quarter are progressing extremely well. We remain focused on optimizing our existing commercial process, including enhancing our emphasize on larger institutional and enterprise customers that are playing an increasingly important role within the industry. As a reminder, Our goal is to add deep TMS technology into this expanding large mental health group or networks. The recent order of 30 new deep TMS systems by a large growing TMS network of clinics is indicative of our execution of this strategy. Moreover, our international business continues to perform well. Most recently, in India, following a serious successive multi-system order, ASHA Neuromodulation Clinics and its affiliate will own 25 deep TMS systems. As the world's most populous country, India represents a key international market for Brainsway. Importantly, the resumed momentum we saw in our business during the first quarter continued in the second quarter, and our outlook for the second half of this year is positive as well. On the top line, our second quarter revenues increased 18% sequentially as compared to the first quarter of 2023, and we shipped a net total of 53 systems during the second quarter. Moreover, demand for OCD treatment indication continues to grow as we shipped 34 OCD calls as add-on elements to certain new and existing systems. Nearly 50% of our total install base now includes OCD treatment capability. Our second quarter bottom line included some of the benefits of the cost optimization measures we executed on earlier this year, as we achieved significant improvement in operating and adjusted EBITDA results. We expect this improvement will become even more apparent in the second half of this year. In addition, we continue to be supported by an extremely strong balance sheet, having ended the first half of the year with 43 $43.4 million in cash and with no debt. As our second quarter results indicate, we are confident that our business is trending in the right direction, and we look forward to further progress in the second half of this year. Moving on to R&D, you will recall that we launched an investigator-initiated study program earlier this year that is designed to support further research on deep TMS by the clinical research community through data collaboration and equipment loan initiatives. The program will aid the investigator interested in advancing current knowledge about deep TMS. We received over 30 applications through the July 3rd deadline, and our research committee is currently evaluating each one. We intend to accept 10 candidates to further advance this original research and will update you on the area selected for additional work in the coming months. On the reimbursement front, Aetna now allows TMS treatment to be ordered and administered under the supervision of behavioral health nurse practitioners for patients with MDD and has removed the previously required four-month psychotherapy trial before patients become eligible to receive an initial course of treatment with TMS. These policy changes impact nationwide commercial plans, covering 16.8 million covered lives. Additionally, Blue Cross Blue Shield of Michigan recently issued a health care policy update reducing the number of antidepressant medication attempts from four down to two prior to TMS treatment eligibility. We also continue to build clinical evidence in support of deep TMS. Most recently, we had three papers published highlighting deep TMS in multiple leading peer-reviewed medical journals. Two of the papers, one published in Brain Stimulation and the other in the journal Clinical Psychiatry, underscored the favorable safety profile of deep TMS. The third paper, published in Brain Sciences, is Comprehensive Review of Existing Evidence of the Use of TMS in Addressing Multiple Addictions including our existing indication of smoking addiction, as well as other potential areas requiring more research, such as alcohol use disorder. Finally, I would like to welcome Ido Marom to BrainSway. Ido recently joined as CFO and significantly strengthened our management team. He is an experienced senior financial leader in global industries, including medical technology. We look forward to a significant contribution as we continue to grow our business as a global leader in TMS industry. Before we review our financial results, I would like to reiterate our confidence in Braintrade's outlook for full year 2023. As a reminder, we continue to expect to demonstrate revenue growth over 2022 and are targeting break-even operating income and positive adjusted EBITDA in the fourth quarter. The market dynamic continues to show that TMS is a large market with strong momentum and there is ample room for BrainSway to capture meaningful market share, both in the U.S. and internationally. With that, I will now turn the call over to Ido for his review of our second quarter of 2023 financial results. Ido?

Disclaimer

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